FDA Device recall Z-0443-2019
bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134 by Biomerieux, citing some eluates become colored because of remaining hemoglobin in the eluate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0443-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-08 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, WI |
Product
bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
Reason
Some eluates become colored because of remaining hemoglobin in the eluate.
Identifiers
| code_info | Lot Z019EA1LB Exp. 28-MAY-2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0443-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.